Client:

A startup medical device company, founded in 2004, specializes in the
development of an effusive stent.

Challenges:

The client is a startup and has limited resources to devote to the clinical study process.
The personnel in the company are best suited to product development, design testing,
clinical monitoring and interpreting results; not setting up and running the clinical study,
particularly from a data collection standpoint.

How we helped based on specifications created by client:

-Configured Clinical Data Management System (Oracle Clinical)
-Managed the clinical data collection, data entry, and validation process

Specification:

-Designed and implemented the data management plan and edit check
-Implemented CDMS verification logic for study data entry
-Enabled the company's R&D team to focus its limited resources on high value
-Allowed management to focus its energies on running the company
-Added activities in the refinement of the product
-Not on clinical trial management